[Federal Register Volume 74, Number 167 (Monday, August 31, 2009)]
[Proposed Rules]
[Pages 44797-44798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20683]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

[DoD-2008-HA-0090; RIN 0720-AB23]


TRICARE; Off-Label Uses of Devices; Partial List of Examples of 
Unproven Drugs, Devices, and Medical Treatments or Procedures

AGENCY: Office of the Secretary, Department of Defense.

ACTION: Proposed rule.

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SUMMARY: The Department of Defense is publishing this proposed rule to 
revise the definition of ``unlabeled or off-label drug'' to ``off-label 
use of a drug or device.'' This revision is consistent with the 
regulatory framework under the Federal Food, Drug, and Cosmetic Act. 
Additionally, this rule removes the partial list of examples of 
unproven drugs, devices, and medical treatments or procedures 
proscribed in TRICARE regulations. As it is determined that reliable 
evidence demonstrates that previously unproven drugs, devices, and 
medical treatments or procedures have proven medical effectiveness, 
TRICARE has removed them from the list and authorized medically 
necessary care. This revision removing the partial list is necessary as 
the list will never be completely current, and is only a partial list 
of examples. The removal of this partial list does not change or 
eliminate any benefits that are currently available under the TRICARE 
program.

DATES: Written comments received at the address indicated below by 
October 30, 2009 will be accepted.

ADDRESSES: You may submit comments, identified by docket number and/or 
Regulatory Information Number (RIN) number and title, by either of the 
following methods:
     Federal Rulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Federal Docket Management System Office, 1160 
Defense Pentagon, Washington, DC 20301-1160.
    Instructions: All submissions received must include the agency name 
and docket number or RIN for this Federal Register document. The 
general policy for comments and other submissions from members of the 
public is to make these submissions available for public viewing on the 
Internet at http://www.regulations.gov as they are received without 
change, including any personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT: Ren[eacute] L. Morrell, TRICARE 
Management Activity, Medical Benefits and Reimbursement Branch, 
telephone (303) 676-3618.

SUPPLEMENTARY INFORMATION: This proposed rule revises the definition of 
``unlabeled or off-label drug'' to ``off-label use of a drug or 
device.'' This revision is consistent with the regulatory framework 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
Additionally, this proposed rule removes the partial list of examples 
of unproven drugs, devices, and medical treatments or procedures 
proscribed under Sec.  199.4(g)(15).

Off-Label Uses of Devices

    On January 6, 1997, the Office of the Secretary of Defense 
published a final rule in the Federal Register (62 FR 627-631) 
clarifying the TRICARE exclusion of unproven drugs, devices, and 
medical treatments or procedures and adding the TRICARE definition of 
unlabeled or off-label drugs. This rule also added the provision for 
coverage of unlabeled or off-label uses of drugs that are Food and Drug 
Administration (FDA) approved drugs that are prescribed or administered 
by a health care practitioner and are used for indications or 
treatments not included in the approved labeling. We are now modifying 
the definition of ``unlabeled or off-label drug'' to ``off-label use of 
a drug or device'' to be consistent with the regulatory framework under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
However, this proposed rule does not present new agency policy. Rather, 
it corrects an error and omission from the current rule. Coverage is 
limited to those indications for which there is reliable evidence, as 
defined in section 199.2, sufficient to establish that the off-label 
use is safe, effective, and in accordance with nationally accepted 
standards of practice in the medical community. In addition, the off-
label use must be reviewed for medical necessity.

Partial List of Examples of Unproven Drugs, Devices, and Medical 
Treatments or Procedures

    By law, TRICARE can only cost-share medically necessary supplies 
and services. Any drug, device, and medical treatment or procedure, the 
safety and efficacy of which have not been established, as described in 
Sec.  199.4(g)(15), is unproven and cannot be cost-shared by TRICARE 
except as authorized under Sec.  199.4(e)(26). The current regulation 
and program policy provide a partial list of examples of unproven 
drugs, devices, and medical treatments or procedures that are excluded 
from benefits. The intent of this partial list was to provide 
information on specific examples of emerging drugs, devices, and 
medical treatments or procedures determined to be unproven by TRICARE 
based on review of current reliable evidence. Due to the rapid and 
extensive changes in medical technology it is not feasible to maintain 
this list in the regulation. Removal of this partial list of examples 
does not change the exclusion of unproven drugs, devices, and medical 
treatments or procedures. Removal of the partial list of examples does 
not change the process TRICARE follows in determining for purposes of 
benefit coverage when a drug, device, and medical treatment or 
procedure has moved from the status of unproven to proven medical 
effectiveness. The intent of this revision is to ensure that benefit 
determinations are made based on current reliable evidence rather than 
relying on outdated regulatory and policy provisions.

Regulatory Procedures

Executive Order 12866, ``Regulatory Planning and Review''

    Section 801 of Title 5, U.S.C., and Executive Order (E.O.) 12866 
require certain regulatory assessments and procedures for any major 
rule or significant regulatory action, defined as one that would result 
in an annual effect of $100 million or more on the national economy or 
which would have other substantial impacts. It has been certified that 
this rule is not an economically significant rule, however, it is a 
regulatory action which has been reviewed by the Office of Management 
and Budget as required under the provisions of E.O. 12866.

Sec. 202, Public Law 104-4, ``Unfunded Mandates Reform Act''

    It has been certified that this rule does not contain a Federal 
mandate that may result in the expenditure by State, local and tribal 
governments, in aggregate, or by the private sector, of $100 million or 
more in any one year.

[[Page 44798]]

Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)

    The Regulatory Flexibility Act (RFA) requires each Federal agency 
prepare, and make available for public comment, a regulatory 
flexibility analysis when the agency issues a regulation which would 
have a significant impact on a substantial number of small entities. 
This proposed rule will not significantly affect a substantial number 
of small entities for purposes of the RFA.

Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)

    This rule will not impose significant additional information 
collection requirements on the public under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501-3511). Existing information collection 
requirements of the TRICARE and Medicare programs will be utilized.

Executive Order 13132, ``Federalism''

    This proposed rule has been examined for its impact under E.O. 
13132 and it does not contain policies that have federalism 
implications that would have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government; therefore, consultation with State and local 
officials is not required.

List of Subjects in 32 CFR Part 199

    Claims, dental health, health care, health insurance, individuals 
with disabilities, Military personnel.

    Accordingly, 32 CFR part 199 is proposed to be amended as follows:

PART 199--[AMENDED]

    1. The authority citation for 32 CFR part 199 continues to read as 
follows:

    Authority:  5 U.S.C. 301; 10 U.S.C. chapter 55.

    2. Section 199.2(b) is amended by removing the definition of 
Unlabeled or Off-Label Drugs and adding a new definition of Off-Label 
Use of a Drug or Device in alphabetical order to read as follows:


Sec.  199.2  Definitions.

* * * * *
    (b) * * *
* * * * *
    Off-Label Use of a Drug or Device. A use other than an intended use 
for which the drug or device is legally marketed under the Federal 
Food, Drug, and Cosmetic Act. This includes any use that is not 
included in the approved labeling for an approved drug or approved 
device; any use that is not included in the cleared statement of 
intended use for a device that has been determined by the Food and Drug 
Administration (FDA) to be substantially equivalent to a legally 
marketed predicate device and cleared for marketing; and any use of a 
device for which a manufacturer or distributor would be required to 
seek pre-market review by the FDA in order to legally include that use 
in the device's labeling.
* * * * *
    3. Section 199.4 is amended by revising the third paragraph of the 
Note to paragraph (g)(15)(i)(A), and removing paragraph (g)(15)(iv) as 
follows:


Sec.  199.4  Basic program benefits.

* * * * *
    (g) * * *
    (15) * * *
    (i) * * *
    (A) * * *

    Note:  * * * CHAMPUS will consider coverage of off-label uses of 
drugs and devices that meet the definition of Off-Label Use of a 
Drug or Device in Section 199.2(b). Approval for reimbursement of 
off-label uses requires review for medical necessity, and also 
requires demonstrations from reliable evidence, as defined in Sec.  
199.2, that the off-label use of the drug or device is safe, 
effective and in accordance with nationally accepted standards of 
practice in the medical community.

* * * * *

    Dated: August 21, 2009.
Patricia L. Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. E9-20683 Filed 8-28-09; 8:45 am]
BILLING CODE 5001-06-P